U.S. patent number 6,755,854 [Application Number 09/919,491] was granted by the patent office on 2004-06-29 for control device and mechanism for deploying a self-expanding medical device.
This patent grant is currently assigned to Advanced Cardiovascular Systems, Inc.. Invention is credited to Matthew J. Gillick, Kent C. B. Stalker.
United States Patent |
6,755,854 |
Gillick , et al. |
June 29, 2004 |
**Please see images for:
( Certificate of Correction ) ** |
Control device and mechanism for deploying a self-expanding medical
device
Abstract
A control device and mechanism for deploying a self-expanding
medical device includes an actuating mechanism which allows the
user to retract a restraining sheath from the self-expanding
medical device by using a motion that is in angle to the line of
motion of the restraining sheath, which helps prevent movement of
the catheter portion of the control device within the patient. The
control mechanism allows the physician to obtain a longer
retracting stroke to the restraining sheath with a shorter
actuating motion reducing the amount of manual actuation needed to
be performed by the physician when retracting the sheath. The
control mechanism can also reduce the amount of actuating force
needed to retract the restraining sheath by utilizing springs or
biasing members in connection with the actuating mechanism which
combines with the actuating force supplied by the physician to
cause the retraction of the restraining sheath.
Inventors: |
Gillick; Matthew J. (Temecula,
CA), Stalker; Kent C. B. (San Marcos, CA) |
Assignee: |
Advanced Cardiovascular Systems,
Inc. (Santa Clara, CA)
|
Family
ID: |
25442184 |
Appl.
No.: |
09/919,491 |
Filed: |
July 31, 2001 |
Current U.S.
Class: |
623/1.11 |
Current CPC
Class: |
A61F
2/95 (20130101); A61M 2025/0681 (20130101); A61F
2/9517 (20200501) |
Current International
Class: |
A61F
2/06 (20060101); A61F 002/06 () |
Field of
Search: |
;623/1.11,1.13,1.15,903
;606/108,191,194,198,200 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Bui; Vy Q.
Attorney, Agent or Firm: Fulwider Patton Lee & Utecht,
LLP
Claims
What is claimed is:
1. A control device for deploying a self-expanding medical device
within a body vessel, the control device comprising: a restraining
sheath having a proximal end and a distal end, the restraining
sheath being adapted to extend over a self-expanding medical device
to maintain the medical device in a collapsed position and to be
retractable to expose the collapsed medical device for deployment;
and a control mechanism including a slider assembly coupled to the
proximal end of the restraining sheath for retracting the
restraining sheath, the slider assembly being movable in a line of
motion, the retraction of the restraining sheath being actuated by
an actuating force applied by a user to a movable component of the
control mechanism which moves in a linear path which is at a
constant angle substantially different from zero degree to the line
of motion of the slider assembly.
2. The control device of claim 1, wherein: the angle at which the
actuating force is to be applied to the movable component of the
control mechanism is between about 30 and 90 degrees with the line
of motion of the slider assembly.
3. The control device of claim 1, wherein: the angle at which the
actuating force is to be applied to the movable component of the
control mechanism is substantially perpendicular to the line of
motion of the slider assembly.
4. The control device of claim 1, wherein: the actuating force
placed on the movable component of the control mechanism causes
translation of the movable component, the control mechanism causing
the length of retraction of the restraining sheath to be larger
than the length of translation of the movable component.
5. The control device of claim 4, wherein: the control mechanism
includes means for varying the length of retraction of the
restraining sheath in response to the length of translation of the
movable component.
6. The control device of claim 4, wherein: the control mechanism
includes means for reducing the amount of actuating force needed to
translate the movable component to fully retract the restraining
sheath from the medical device.
7. The control device of claim 6, wherein: the means for reducing
the amount of actuating force needed to translate the movable
component are biasing means coupled to the movable component which
places a force on the movable component in the direction of
translation of the movable component.
8. The control device of claim 1, further including: an elongate
inner member upon which the restraining sheath is coaxially
disposed, the inner member having a proximal end coupled with the
control mechanism and a distal end having a mounting portion for
mounting the self-expanding medical device.
9. The control device of claim 8, further including: a housing for
the control mechanism, the proximal end of the restraining sheath
being movable in the housing in a line of motion with the proximal
end of the inner member being affixed within the housing to
maintain the inner member stationary as the restraining sheath is
being retracted.
10. The control device of claim 9, wherein: the control mechanism
includes a movable rack and pinion assembly mounted within the
housing, the movable component being a movable rack adapted to
receive the actuating force for retracting the retraining sheath,
the pinion being coupled with the slider assembly.
11. A control device for deploying a self-expanding medical device
within a body vessel, the control device comprising: a housing; a
catheter system coupled with the housing, the catheter system
including a restraining sheath having a proximal end and a distal
end and an inner member having a proximal end mounted within the
housing and a distal end having a mounting portion for mounting a
self-expanding medical device, the restraining sheath being
disposed over the inner member with the distal end of the
restraining sheath being extendable over the self-expanding medical
device to maintain the medical device in a collapsed position, the
restraining sheath being retractable to expose the collapsed
medical device for deployment; and a control mechanism mounted
within the housing and including slider assembly coupled to the
proximal end of the restraining sheath for retracting the
restraining sheath, the slider assembly being movable in a line of
motion, the retraction of the restraining sheath being actuated by
an actuating force applied by a user to a movable component of the
control mechanism which moves in a linear path which is at a
constant angle substantially different from zero degree to the line
of motion of the slider assembly.
12. The control device of claim 11 wherein: the proximal end of the
restraining sheath is movable within the housing in a line of
motion with the proximal end of the inner member being affixed
within the housing to maintain the inner member stationary as the
restraining sheath is being retracted.
13. The control device of claim 12, wherein: the control mechanism
includes a movable rack and pinion assembly mounted within the
housing, the movable component being a movable rack adapted to
receive the actuating force for retracting the retraining sheath,
the pinion being coupled with the slider assembly.
14. The control device of claim 13, wherein: the movable rack is
coupled to biasing element which places a force on the movable rack
which reduces the actuating force needed to translate the movable
rack in order to retract the restraining sheath.
15. The control device of claim 11, wherein: the angle at which the
actuating force is to be applied to the moveable component of the
control mechanism is between 30 and 90 with the line of motion of
the sliding assembly.
16. The control device of claim 11, wherein: the angle at which the
actuating force is to be applied to the movable component of the
control mechanism is substantially perpendicular to the line of
motion of the sliding assembly.
17. The control device of claim 11, wherein: the actuating force
placed on the movable component of the control mechanism causes
translation of the movable component, the control mechanism causing
the length of retraction of the restraining sheath to be larger
than the length of translation of the movable component.
18. The control device of claim 17, wherein: the control mechanism
includes means for varying the length of retraction of the
restraining sheath in response to the length of translation of the
movable component.
19. The control device of claim 18, wherein: the control mechanism
includes means for reducing the amount of actuating force needed to
translate the movable component to fully retract the restraining
sheath from the medical device.
20. The control device of claim 19, wherein: the means for reducing
the amount of actuating force needed to translate the movable
component are biasing means coupled to the movable component which
places a force on the movable component in the direction of
translation of the movable component.
21. A control device for deploying a self-expanding medical device
within a body vessel, the control device comprising: an inner
member having a proximal portion and a distal end and being adapted
to receive a self-expanding medical device; a restraining sheath
adapted to extend over the self-expanding medical device to
maintain the self-expanding medical device in a collapsed position,
the restraining sheath being retractable to expose the
self-expanding medical device for deployment; and a control
mechanism mounted within a housing, the control mechanism coupled
with the restraining sheath for moving the restraining sheath to
expose the self-expanding medical device, wherein the proximal
portion of the inner member extends within the housing and defines
a line of motion, the movement of the restraining sheath being
accomplished by an actuating force applied by the user to a control
member which moves in a linear path being at a constant angle
substantially different from zero degree with the line of motion
defined by the proximal portion of the inner member.
22. The control device of claim 21, wherein: the direction of the
actuating force applied by the user to the movable component of the
control mechanism is between about 30 and 90 degrees with the line
of motion defined by the proximal portion of the inner member.
23. The control device of claim 21, wherein: the direction of the
actuating force applied by the user to the movable component of the
control mechanism is substantially perpendicular to the line of
motion defined by the inner member.
24. The new control device of claim 21, wherein: the inner member
includes a lumen for receiving a guide wire.
25. A control device for deploying a self-expanding medical device
within a body vessel, the control device comprising: a housing; a
restraining sheath adapted to extend over the self-expanding
medical device to maintain a self-expanding medical device in a
collapsed position, the restraining sheath being retractable to
expose the self-expanding medical device for deployment; and a
control mechanism associated with the housing and coupled to the
restraining sheath for moving the restraining sheath to expose the
self-expanding medical device, the control mechanism including a
control knob within the housing and a sliding component which moves
substantially linearly within the housing, the sliding component
being coupled to the restraining sheath and being movable by an
actuating motion applied by the user to the control knob, which
control knob moves in a linear fashion to form a constant angle
substantially different from zero degree with the linear movement
of the sliding component.
26. The control device of claim 25, wherein: the movement of the
control knob is substantially perpendicular to the linear movement
of the sliding component.
27. A control device for deploying a self-expanding medical device
within a body vessel, the control device comprising: a restraining
sheath having a proximal end and a distal end, the restraining
sheath being adapted to extend over a self-expanding medical device
to maintain the medical device in a collapsed position and to be
retractable to expose the collapsed medical device for deployment;
an elongate inner member upon which the restraining sheath is
disposed, the inner member having a mounting portion for mounting
the self-expanding medical device; and a housing associated with a
control mechanism, the control mechanism including a slider
assembly movable within the housing and coupled to the proximal end
of the restraining sheath for retracting the restraining sheath in
a line of motion, the control mechanism including a movable rack
and pinion assembly mounted within the housing, the movable rack
being adapted to receive an actuating force for retracting the
retraining sheath, the pinion assembly being coupled with the
slider assembly, a gear connected to the pinion and means
connecting the slider assembly to the gear for translating the
slider assembly when the gear is rotated by the rotation of the
pinion, the retraction of the restraining sheath being actuated by
an actuating force applied by a user to the movable rack which
moves in a linear direction which is at a constant angle
substantially different from zero degree to the line of the
restraining sheath, the proximal end of the inner member being
affixed within the housing to maintain the inner member stationary
as the restraining sheath is being retracted.
28. A control device for deploying a self-expanding medical device
within a body vessel, the control device comprising: a housing; a
catheter system coupled with the housing, the catheter system
including a restraining sheath having a proximal end and a distal
end and an inner member having a proximal end mounted within the
housing and a distal end having a mounting portion for mounting a
self-expanding medical device, the restraining sheath being
disposed over the inner member with the distal end of the
restraining sheath being extendable over the self-expanding medical
device to maintain the medical device in a collapsed position, the
restraining sheath being retractable to expose the collapsed
medical device for deployment, the proximal end of the restraining
sheath being movable within the housing and the proximal end of the
inner member being affixed within the housing to maintain the inner
member stationary as the restraining sheath is being retracted; and
a control mechanism mounted within the housing, the control
mechanism including a slider assembly coupled to the proximal end
of the restraining sheath for retracting the restraining sheath in
a line of motion, the retraction of the restraining sheath being
actuated by an actuating force applied by a user to a movable rack
which moves in a linear direction which is at a constant angle
substantially different from zero degree to the line of motion of
the restraining sheath, the control mechanism including a pinion
assembly coupled with the slider assembly, a gear connected to the
pinion assembly and means connecting the slider assembly to the
gear for translating the slider assembly when the gear is rotated
by the rotation of the pinion.
29. The control device of claim 28, wherein: the gear has a larger
diameter than the pinion to cause the length of retraction of the
restraining sheath to be larger than the length of translation of
the movable rack.
Description
BACKGROUND OF THE INVENTION
The present invention relates to vascular catheters and devices,
and more specifically to a control device for deploying
self-expanding medical devices. Vascular catheters and devices are
currently employed in a variety of medical procedures. These
procedures often require manipulation (or actuation) of the
vascular device by a mechanism located outside the patient's body.
The present invention is specifically useful in deploying
self-expanding medical devices, such as a self-expanding stent or
graft, within a patient's vasculature.
Catheters have long been used in intraluminal procedures for
various medical needs. They generally are made from elongated tubes
which may be placed within various body lumens. A common use for
catheters is the treatment of vascular diseases. Such procedures
usually involve the percutaneous introduction of an interventional
device into the lumen of the artery, usually through the catheter.
One widely known and medically accepted procedure is balloon
angioplasty in which an inflatable balloon is introduced within the
stenosed region of the blood vessel to dilate the occluded vessel.
The uninflated balloon catheter is initially inserted into the
patient's arterial system and is advanced and manipulated into the
area of stenosis in the artery. The balloon is inflated to compress
the plaque and press the vessel wall radially outward to increase
the diameter of the vessel, resulting in increased blood flow. The
balloon is then deflated to a small profile so that the dilatation
catheter can be withdrawn from the patient's vasculature. Enhanced
blood flow should now resume in the dilated artery. As should be
appreciated by those skilled in the art, while the above-described
procedure is typical, it is not the only method used in
angioplasty.
In the procedure of the kind referenced above, abrupt reclosure may
occur or restenosis of the artery may develop over time, which may
require another angioplasty procedure, a surgical bypass operation,
or some other method of repairing or strengthening the injured
area. To reduce the likelihood of the occurrence of abrupt
reclosure and to strengthen the area, a physician can implant an
intravascular prosthesis for maintaining vascular patency, commonly
known as a stent, inside the artery across the lesion. The stent
can be crimped onto the balloon portion of the catheter and
transported in its delivery diameter through the patient's
vasculature. At the deployment site, the stent is expanded to a
larger diameter, often by inflating the balloon portion of the
catheter.
A variety of stent designs have been developed and include
self-expanding stents insertable and deliverable through the
patient's vasculature in a compressed state for deployment in a
body. Unlike balloon expandable stents which rely on an external
radial force to expand the stent at the area of treatment,
self-expanding stents are made from materials which are
self-expanding in order to move between a compressed or collapsed
position to an expanded, implanted position. Stent delivery
catheters used for implanting self-expanding stents usually include
an inner member upon which the compressed or collapsed stent is
mounted and an outer restraining sheath placed over the stent to
maintain it in its compressed state prior to deployment. When the
stent is to be deployed in the body vessel, the outer restraining
sheath is retracted in relation to the inner member to uncover the
compressed stent, allowing the stent to immediately move into its
expanded condition for implantation in the patient.
Vascular grafts also can be implanted within a body vessel
utilizing a delivery catheter which is percutaneously introduced
into the patient's vasculature system. These types of grafts may
include a number of self-expanding rings, or small stents, placed
along a flexible tubular member that forms a conduit once implanted
in a body vessel. Vascular grafts are utilized to bypass diseased
and weakened body vessels, such as when an artery experiences an
aneurysm which weakens and abnormally expands the artery. In this
manner, the vascular graft will act as a conduit for blood to flow
freely there through, bypassing the diseased portion of the
arterial wall caused by the aneurysm. As a result, the chances that
the artery could possibly rupture due to pressure build-up in the
artery is greatly reduced. Self-expanding vascular grafts also can
be mounted onto a delivery catheter which includes a restraining
sheath placed over the entire vascular graft, including the
self-expanding rings, in order to maintain the graft in a collapsed
position. Once the physician is able to manipulate the vascular
graft into the desired location in the patient's vasculature, the
simple retraction of the restraining sheath from the vascular graft
will cause the self-expanding rings or stents to expand and contact
the wall of the body lumen in which the graft is implanted.
These various treatments at the intraluminal site typically require
the manipulation of the catheter system, a portion of which remains
external to the patient's body. The physician must actuate the
catheter system to retract the restraining sheath in order to
properly deploy the stent or vascular graft in the body vessel.
Actuator mechanisms which can be located at the proximal end of the
catherter system may be as simple as a control handle attached to
the restraining sheath that can be manipulated by the physician to
retract the restraining sheath from the self-expanding medical
device. During the placement of a stent or graft, it is important
that the retraction of the restraining sheath be performed while
the main catheter, on which the stent or graft is mounted, remains
stationery in the body lumen. Some control mechanisms for
retracting the restraining sheath requires that some force be
applied by the physician in the longitudinal direction of the
delivery catheter (i.e., in an axial direction). This force, in
turn, can be transmitted to the main catheter assembly which can
cause the stent or graft to move from the desired location within
the body lumen. As the physician retracts the sheath, if the main
catheter holding the stent or graft moves proximally with the
sheath out of the target area, precision placement of the medical
device will not be accomplished. Therefore, when a physician uses
this type of device, the mere act of retracting the restraining
sheath can sometimes result in inaccurate placement of the medical
device within the body vessel.
Another problem exists when self-expanding stents or grafts which
have an appreciable length (for example, 60 mm and longer) are to
be deployed. These larger devices usually are more difficult to
deploy accurately using existing catheter systems because a long
retraction stroke is needed to retract the distal end of the
restraining sheath from the medical device. In such cases, the
physician may experience some difficulties in moving the proximal
control device the required length to fully expose the
self-expanding medical device. Moreover, the deployment of longer
stents and grafts may require higher forces to retract the
restraining sheath due to frictional forces which can be generated
between the stent or graft and the restraining sheath as the sheath
is being retracted. Therefore, the physician may have to apply more
force to adequately retract the restraining sheath when a long
stent or graft is being implanted. Thus, when a long stent or graft
is being implanted, a physician may find it difficult to manipulate
the proximalcontrol device while maintaining the remainder of the
catheter system stationary to prevent the stent or graft from
moving from the desired area of implantation.
Thus, what has been needed is a control mechanism which helps to
provide a more precise deployment of a self-expanding medical
device within the body vessel to reduce the chances that the
physician may inadvertently move the medical device from the
intended area of treatment. An improved control device is also
needed when a long stent or graft to be deployed to reduce the
actuating force which is needed to retract the sheath the required
distance. Such a device also should reduce the length of the
actuating motion which must be applied to the control device when
retracting the restraining sheath. The present invention satisfies
these and other needs.
SUMMARY OF THE INVENTION
The present invention provides a control device and mechanism for
retracting a restraining sheath used in conjunction with
self-expanding medical devices, such as self-expanding stents and
vascular grafts, for implantation in a patient's vasculature.
The control device and mechanism of the present invention are
particularly advantageous since the actuating mechanism allows the
physician to retract the restraining sheath from the self-expanding
medical device by using a motion that is at an angle to the line of
motion of the restraining sheath, which should help to prevent
movement of the catheter portion of the control device within the
patient In one particular aspect of the present invention, the
actuating motion can be substantially perpendicular to the line of
motion of the proximal end of the restraining sheath. As a result,
the physician's manipulation of the control device, when retracting
the restraining sheath, should not place a displacing force on the
inner portion of the catheter which could otherwise cause the stent
or graft to move from the target area. A more accurate placement of
a stent or graft can thus be accomplished by the physician since
the possibility of stent or graft movement is reduced when the
restraining sheath is being retracted. The control mechanism also
allows the physician to deploy a longer stent or graft with a
shorter actuating motion to reduce the amount of manual actuation
performed by the physician when retracting the restraining sheath.
As a result, the physician only needs to push a thumb knob or
trigger a short distance to cause the restraining sheath to retract
a larger distance to fully expose the medical device for
implantation. The present invention also can use springs or biasing
members to reduce the amount of force needed to push the knob or
trigger. As a result, a physician will find that it is much easier
to manipulate a control device made in the present invention
especially when longer stents or vascular grafts are being deployed
in the patient's vasculature.
In one aspect of the present invention, the control device utilizes
a movable rack and pinion mechanism for retracting the proximal end
of the restraining sheath while maintaining the inner catheter
portion, on which the self-expanding medical device is mounted,
stationary. The physician can grasp the control device and utilize
his/her thumb to push a control knob attached to the moveable rack
which causes rotation of a pinion and an attached pulley. Rotation
of the pulley causes a timing belt to translate along the housing
of the control device to move a slider member towards the pulley.
The slider is attached to the proximal end of the restraining
sheath so that when the slider is retracted proximally by the
control mechanism, the distal end of the restraining sheath also
will be retracted proximally the same distance to expose the stent
or vascular graft. The moveable rack is designed to translate in a
direction set at an angle, usually between 30.degree. to
90.degree., to the line of motion defined by the slider/restraining
sheath. As a result, when utilizing this type of mechanism, the
physician does not have to move the control device in the same
axial direction as the motion of the restraining sheath to retract
the sheath for deployment purposes. Thus, the chances of the stent
or vascular graft becoming displaced from the desired area of
implantation in the body vessel is greatly reduced.
In another aspect of the present invention, the ratio of the pulley
pitch diameter to the pinion pitch diameter can be increased to
allow the physician to retract the restraining sheath a longer
distance with only a minimal amount of actuating distance when
manipulating the control knob. As a result, a long stent or graft
can be more easily deployed with a minimal amount of actuating
movement required by the physician. The moveable rack also can be
spring loaded in order to reduce the amount of force needed to move
the control knob when retracting the restraining sheath. In this
manner, the physician does not need to use as much strength when
using the actuating mechanism, which is especially useful when a
long stent or vascular graft is being deployed. In this manner, the
spring or biasing element utilized in conjunction with the moveable
rack assists in pushing the movable rack along with the actuating
motion provided by the physician.
It is to be understood that the present invention is not limited by
the embodiments described herein. Other features and advantages of
the present invention will become more apparent from the following
detailed description of the invention, when taken in conjunction
with the accompanying exemplary drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a control device and control
mechanism embodying features of the present invention.
FIG. 2 is a perspective view of the control device and control
mechanism of FIG. 1 with the top plate removed to better show the
particular control mechanism embodying features of the present
invention.
FIG. 3 is another perspective view showing the particular control
mechanism of FIGS. 1 and 2.
FIG. 4 is a plane view of the control device and control mechanism
of FIGS. 1 and 2.
FIG. 5 is a side elevational view of the control device and control
mechanism of FIGS. 1 and 2.
FIG. 6 is a side elevational view of the distal end of the catheter
portion of the control device which shows a self-expanding stent
being maneuvered into a diseased portion of a body vessel.
FIG. 7 is an elevational view similar to FIG. 6 which shows the
distal end of the restraining sheath being retracted to deploy the
self-expanding stent in the area of treatment in the body
vessel.
FIG. 8 is a side elevational view, partially in cross-section, of
the slider member and timing belt which forms part of the control
mechanism of FIGS. 1 and 2.
FIG. 9 is a side elevational view, partially in cross-section,
taken along line 9--9 showing the moveable rack and pinion system
used in accordance with the present invention.
FIG. 10 is a side elevational view, partially in cross-section,
showing the control knob and moveable rack which forms part of the
control mechanism shown in FIGS. 1 and 2.
FIG. 11 is a side elevational view, partially in cross-section,
showing the control knob of FIG. 10 as it is pushed down to contact
the moveable rack when an actuating motion is to be applied to the
control knob.
FIG. 12 is a perspective view of another embodiment of a control
device and control mechanism made in accordance with the present
invention.
FIG. 13 is an exploded perspective view of the control device and
control mechanism of FIG. 12.
FIG. 14 is a plan view showing the control mechanism located in the
control device of FIGS. 12 and 13.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Turning now to the drawings, in which like reference numerals
represent like or corresponding elements in the drawings, FIGS. 1-4
illustrate a control device 20 incorporating features of the
present invention. This control device 20 is adapted for use with a
medical device, such as a self-expanding stent or vascular graft.
FIGS. 1-4 show a particular embodiment of a control device 20
incorporating features of the present invention which includes a
housing 22 in which a control mechanism 24 (see FIGS. 2-4) is
mounted. The control device 20 includes a catheter portion
including a restraining sheath 26 which extends out from the
housing 22 and extends to a distal end 28 where a self-expanding
medical device, such as a stent 30 (see FIGS. 6 and 7) is
maintained in a collapsed state ready for delivery into the
patient's vasculature. The control device 20 includes a control
knob 32 (FIG. 1) which can be manipulated by the physician to
retract the restraining sheath 26 to deploy the stent 30 in the
body vessel. This control knob 32 moves along a slot 34 in a top
plate 36 which forms part of the housing 22. A bottom plate 38,
shown better in FIGS. 2 and 3, forms the lower part of the housing
22 upon which the control mechanism 24 is mounted.
In use, the physician grasps the hand portion 40 of the control
device and utilizes his/her thumb or index finger to move the
control knob 32 in an upward motion to retract the restraining
sheath 26 in order to deploy the stent 30. This control knob 32 is
connected to a moveable rack 42 which remains in contact with a
pinion gear 44 that is mounted onto a hub 46 formed on the bottom
plate 38. The translation of the moveable rack 42 causes the pinion
gear 44 to rotate which in turn rotates another gear or pulley 48
attached to the pinion gear 44. This pulley 48 is in turn connected
to a timing belt 50 connected to a slider 52 that translates in a
channel 54 formed on the bottom plate 38. This slider 52 is
connected to the proximal end 56 of the restraining sheath 26 and
causes the proximal end 56 to retract back in a linear motion
within the housing 22 as the timing belt 50 moves the slider 52
proximally towards the pulley 48. In this manner, the distal end 28
of the restraining sheath 26 is retracted back to deploy the
self-expanding stent 30.
As can be seen by the particular construction of this control
mechanism 24, the travel of the slider 52 on the control device 20
is made in a line of motion which is accordingly parallel to the
line of travel of the proximal end of the restraining sheath 26.
The moveable rack 42, which is manipulated by the physician via the
control knob 32, also translates in a linear motion that is
substantially perpendicular to the line of motion of the slider 52
and, hence, the restraining sheath. In this manner, the physician
can manipulate the proximal end 56 of the restraining sheath 26
with a hand motion which should not cause the stent 30 to move
longitudinally within the body vessel once positioned in the
patient's vasculature. Thus, a more precision placement of the
medical device can be made by the physician since the risk of
moving the self-expanding device with the retraction of the sheath
is greatly reduced.
Referring specifically to FIG. 4, the hand portion 40 and moveable
rack (not shown in FIG. 4) are substantially perpendicular to the
line of motion of the slider 52 within the channel 54 formed on the
bottom plate 36 of the housing 22. A dotted line designated "A" in
FIG. 4 shows the substantial 90.degree. angle which the hand
portion 40 and moveable rack 42 makes with the line of motion for
the slider 52 and restraining sheath 26. Also, as is shown in FIG.
4, the hand portion 40 and moveable rack 42 could be placed at
other angles besides 90.degree. to the line of motion for the
slider/sheath. For example, dotted lines "B" and "C" in FIG. 4 show
the locations where the hand portion 40 and movable rack 42 could
be positioned from the line of motion of the slider/sheath as well.
This angle is shown to be about 30..degree. The position of the
hand portion 40 and moveable rack 42 could be anywhere between
these dotted lines "B" and "C" if desired. If an angle of less than
about 30.degree. is utilized, there still exists the possibility
that the actuation of the control knob by the physician may cause
some longitudinal movement to the catheter portion which will in
turn move the placement of the stent or graft within the patient's
vasculature. However, if the hand portion 40 and moveable rack 42
are located somewhere between dotted lines "B" and "C", there
should be a minimal chance of catheter movement when the control
knob is manipulated by the physician.
As can be seen in FIGS. 6 and 7, the stent 30 is mounted onto a
mounting component 58 located at the distal end 28 of the
restraining sheath 26. This mounting component 58 is in turn
attached to an inner member 60 which extends coaxially with the
restraining sheath 26 and is mounted within the control device 20.
This inner member 60 and mounting component 58 also form a part of
the catheter portion of the device 20. This inner member 60 extends
through an opening 62 in the housing 22 to a leur fitting 64 which
connects to the proximal end 66 of the inner member 60. This inner
member 60 serves as a conduit for receiving a guide wire 68 (see
FIGS. 6 and 7) utilized to deliver the medical device into the
patient's artery, as will be explained in greater detail below.
This inner member 60 can be made from a hypotube or other similar
materials which provides axial strength to the catheter system. In
use, this inner member 60 and the mounting component 58 must remain
relatively stationary during the deployment of the stent otherwise
the stent may be improperly implanted in the patient's vasculature.
An obturator 70 creates an atraumatic tip for the catheter portion
of the control device to prevent snowplowing of the distal end of
the restraining sheath 26 as it moves through the patient's
vasculature in an over-the-wire fashion along the guide wire 68. As
can be seen in FIG. 6, this obturator is coned-shaped and is flush
with the outer surface of the restraining sheath 26 to create a
relatively smooth surface that helps to prevent snowplowing from
occurring in the patient's vasculature.
In use, the self-expanding stent 30 would be delivered within a
body vessel of the patient, such as an artery 72, as shown in FIGS.
6 and 7. The delivery of the stent 30 can be accomplished in the
following manner. The stent 30 is first mounted onto the mounting
component 58 of the inner catheter member 60 with the restraining
sheath 26 being placed over the contracted stent. The
catheter/stent assembly can then be introduced within the patient's
vasculature in a conventional Seldinger technique through a guiding
catheter (not shown). The guide wire 68 would be initially steered
into the area of treatment where a stenosis 74 is located. The
catheter/stent would then be advanced over the guide wire 68 until
the stent 30 is directly under the stenosis 74. The restraining
sheath 26 can then be retracted, allowing the stent 30 to expand to
its larger diameter to press upward against the artherosclerosic
plaque which has built up on the vessel wall, as illustrated in
FIG. 6. While not shown in the drawing, the artery 72 is preferably
expanded slightly by the expansion of the stent 30 to seat or
otherwise fix the stent 30 to prevent movement. In some
circumstances during the treatment of the stenoic portions of an
artery, the artery may have to be expanded considerably in order to
facilitate passage of blood or other fluid therethrough. Once the
restraining sheath 26 is retracted to expose the stent, as shown in
FIG. 7, the stent will expand and compress the stenosis somewhat to
enlarge the lumen through which blood flows.
It should be appreciated that although the stent 30 is shown being
utilized to treat an area in which artherosclerosic plaque has
built up against the wall of an artery, it could also be used to
hold up a detached lining, or other abnormality, of the patient.
Moreover, the stent 30 can be utilized in any one of a number of
different body vessels, including but not limited to carotid
arteries, coronary arteries and renal arteries. The stent could be
used for primary stenting purposes, i.e., to directly enlarge the
opening in the artery, or it could be utilized in conjunction with
predilitation in which the stenoic plaque is initially expanded in
the area of treatment by a balloon dilitation catheter. Thereafter,
the stent 30 could be placed in the predilitated area of treatment
to help restenosis and to maintain this diseased portion of the
artery in an open position. As indicated above, the present
invention can also be utilized in conjunction with other
self-expanding medical devices, for example, a self-expanding graft
which could be delivered to a particular area in the patient's
vasculature for providing a fluid conduit that bypasses a diseased
portion of a vessel wall to prevent the vessel wall from
rupturing.
As is shown in FIGS. 6 and 7, as the restraining sheath 26 is
retracted past the self-expanding stent, the proximal end 76 of the
stent 30 may come in contact with a radiopaque marker 78 located on
the mounting component 58 to provide a source of visualization for
the physician during placement of the stent in the patient's
vasculature. This radiopaque marker 78 serves as an abutting
shoulder to help prevent the stent 30 from moving back with the
restraining sheath as it is being retracted due to the frictional
forces which may be generated between the moving sheath and outer
surface of the stent. In this manner, the possibility that the
stent can be pulled back along with the restraining sheath is
reduced.
Referring specifically now to FIG. 8, the particular attachment
utilized to connect the proximal end 56 of the restraining sheath
26 to the slider 52 is shown in greater detail. As can be seen in
FIG. 8, the slider 52 translates within a channel 54 formed in the
bottom plate 38 of the control handle 20 which follows the line of
travel of the restraining sheath. The slider 52 includes an opening
80 through which the inner catheter member 60 and the proximal end
56 of the restraining sheath 28 extend through. However, the
proximal end 56 of the restraining sheath 26 would be bonded within
this opening 80 utilizing adhesives or other attachment techniques
well-known in the art. As such, it would be securely affixed to the
slider 52 and will move with the slider as it moves proximally
towards the pulley 48 in the direction of the arrow 81 shown in
FIG. 4. It should be appreciated that the restraining sheath 26
remains in a coaxial arrangement with the inner catheter member 60
as the restraining sheath 26 moves along the length of the inner
catheter member 60 during deployment. The control mechanism 24 also
helps to prevent the restraining sheath 26 from retracting
prematurely since the slider 52 will remain at its position as
shown in FIG. 4 until the pulley 48 is rotated via the action of
the moveable rack 42. It should be appreciated by those skilled in
the art that although a timing belt 50 is shown attached to the
slider 52, the control mechanism could also utilize cables, pulleys
and movable racks, and the like, to accomplish this same motion.
Again, the deployment motion could be at an angle other than
90.degree. to the line of motion of the retraining sheath. It also
should be appreciated that the configuration of the hand portion
could be altered to allow deployment of the stent by a whole hand
motion, or by use of an individual finger, such as the thumb.
Although a control knob 32 is shown and described as providing the
mechanism for providing an upward motion to the moveable rack 42,
the direction of this actuating motion could be in a opposite
direction without departing from the spirit and scope of the
present invention.
The control device 20 also may include a distal hub 82 at which a
strain relief member 84 is located. This strain relief member 84
helps to prevent unwanted bending of the restraining sheath 26 at
the distal end of the control device. Conventional strain relief
components could be utilized in accordance with the present control
device as illustrated in FIGS. 1-4.
Referring now to FIGS. 4 and 9-11, the moveable rack 42 and control
knob 32 are shown in greater detail. As can be seen in FIG. 9, the
moveable rack 42 also translates within a channel 86 formed in the
bottom plate 38 of the control handle 20. In this particular
embodiment, the moveable rack 42 is designed to translate in a
direction substantially perpendicular to the line of travel of the
slider 52 and restraining sheath 26. The control knob 32 can be
mounted onto the top plate 36 which forms part of the housing 22 in
such a manner that the control knob will not engage the moveable
rack 42 (as is shown in FIG. 10) until the physician is ready to
retract the sheath 26. In this regard, a biasing element such as a
spring (not shown) can be utilized to maintain the control knob 32
in an upright position (as shown in FIG. 10) until the physician
desires to retract the restraining sheath 26. Thereafter, a slight
downward push of the control knob 32 will engage the top portion of
the moveable rack (as is shown in FIG. 11) to allow the physician
to move the control knob 32 and movable rack 42 to retract the
restraining sheath 26. Again, it should be appreciated that this is
just one form of a control knob which can be utilized in accordance
with the present invention and other variations of this actuating
mechanism can be utilized without departing from the spirit and
scope of the present invention.
Referring now specifically to FIG. 4, the diameters of the pinion
gear 44 and pulley 48 can be seen. The upper pinion gear 44 has a
smaller diameter than the pulley 48 utilized to translate the
slider 52 within the channel 54. As a result, a particular ratio
can be achieved which will result in a longer retracting stroke
being applied to the restraining sheath 26 as the physician moves
the control knob 32 to translate the moveable rack 42. In this
manner, a greater retraction stroke can be achieved on the
restraining sheath 26 by a smaller hand motion provided by the
physician. This feature is certainly beneficial to the physician
since less hand actuating would be required on his/her part in
order to translate the restraining sheath a longer distance. This
is particularly advantageous when a long stent is being deployed in
the patient's vasculature which usually requires a long retracting
stroke to fully retract the restraining sheath. This particular
feature can be advantageous when a self-expanding vascular graft is
the component to be deployed since vascular grafts are usually
longer than self-expanding stents. It should be appreciate that any
number of different gear ratios can be achieved in order to reduce
the amount of hand motion needed by the physician to actuate the
device while still achieving the desired retraction stroke to the
sheath.
Although it is not shown in FIGS. 1-4, this moveable rack 42 can
also be spring loaded to lower the force needed to be supplied by
the physician when moving the control knob 32 to retract the
restraining sheath 26. Such a spring could be located at the end of
the moveable rack 42 to provide an external force to the moveable
rack 42 as the control knob 32 is being manipulated by the
physician. As a result, the physician need not apply as much force
to move the control knob. Again, this feature can be useful when
long stents or vascular grafts are being deployed since greater
force is usually needed due to the increased amount of frictional
contact created between the moving inner surface of the restraining
sheath and the outer surface of the stent or graft.
Referring now to FIGS. 12-14, another embodiment of a control
device 100 and control mechanism 102 made in accordance with the
present invention is shown. In this particular embodiment, the
control device 100 includes a housing 22 which include a bottom
plate 38 and a top plate 36. This particular control device 100 and
control mechanism 102 operates substantially as the previously
described control device 20 in that the physician applies an
actuating motion to the trigger 104 in a direction which is at an
angle to the linear motion of the slider/restraining sheath in the
housing. This angle can be between 30.degree. and 150.degree. with
90.degree. being and optional angle when deploying the medical
device. Referring specifically to FIGS. 13 and 14, the control
device 100 includes a trigger 104 connected to a moveable rack 42
which contacts a pinion gear 44. A second moveable rack 106 which
is attached to the proximal end of the restraining sheath 26 is in
contact with this gear 44 or a second pulley or gear (not shown).
As a result, the second moveable rack 106 moves in a linear motion
that is at a substantially 90.degree. angle to the motion of the
first moveable rack 42. The trigger 104 of the control device 100
is designed with several openings 108 and 110 which are adapted to
fit different sized hands of the physician using the control
handle. In this manner, the movement of the trigger 104 by the
physician should not cause the self-expanding medical device to
move from the target in the patient's vasculature.
Referring specifically to FIG. 14, the second moveable rack 106 is
shown as it is placed within a channel 112 formed in the bottom
plate 38. The moveable rack 42 is also contained within a channel
54 and is, of course, attached to the trigger 104. In this
particular embodiment, the gear ratio between the pinion gear 44
and the second gear also can be set so that only a small amount of
actuating motion of the trigger will produce a long retraction
stroke to the restraining sheath. The control device can be
equipped with a spring loaded mechanism 114 which contacts the
moveable rack 42 to provide a force which lowers the force which
would be required by the physician when moving the trigger 104. For
example, a spring 116 can be located in the channel 54 to contact
one end of the moveable rack 42 to apply external force to the rack
which again will help to reduce the amount of force needed when
actuating the trigger.
The components of the present invention can be made from
conventional plastics and polymeric materials known in the art. The
lengths of the various components can vary depending upon the
particular uses intended. For example, the length of the catheter
portion of the control device can vary depending on the particular
type of medical device to be implanted, the target location and the
type of procedure to be administered.
Further modifications and improvements may additionally be made to
the device and method disclosed herein without departing from the
scope of the present invention. Accordingly, it is not intended
that the invention be limited, except as by the appended
claims.
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